Actively Recruiting
A Randomized, Double-Blind, Placebo-Controlled Study of Depemokimab Added to Standard Care in Adults With Moderate to Severe COPD and Type 2 Inflammation
Led by GlaxoSmithKline · Updated on 2025-10-08
981
Participants Needed
15
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating depemokimab as an additional treatment for adults with moderate to severe chronic obstructive pulmonary disease (COPD) who have uncontrolled symptoms and type 2 inflammation. This Phase 3 study aims to assess the safety and effectiveness of depemokimab in reducing COPD flare-ups compared to a placebo, with the goal of improving patient outcomes. Participants will be randomly assigned to receive either depemokimab or a placebo alongside their standard COPD care. Depemokimab is given as a sterile liquid formulation, while the placebo is a sterile sodium chloride solution. The study is double-blind, meaning neither participants nor researchers know which treatment is given. Treatment and observation will continue for up to 104 weeks, allowing thorough assessment over two years. During the study, participants will undergo regular evaluations including lung function tests, symptom questionnaires like the COPD assessment test and St. George's Respiratory Questionnaire, and monitoring of exacerbations requiring medical attention. Researchers will track the annual rate of moderate to severe COPD exacerbations as the primary outcome. Safety will be closely monitored throughout the trial, and participants' health status will be reviewed periodically until study completion, which may last until August 2029.
CONDITIONS
Brief Title
Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (ENDURA -1)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 40 to 80 years at the time of consent
- Elevated blood eosinophil count
- Moderate to severe COPD with frequent exacerbations for at least 1 year
- Post-bronchodilator FEV1/FVC ratio < 0.70 and FEV1 >30% to ≤80% predicted
- History of at least 2 moderate or 1 severe exacerbation in past 12 months
- COPD assessment test (CAT) score ≥10 at first visit
- Current or former smoker with ≥10 pack-years
- On inhaled corticosteroid plus LAMA plus LABA therapy for at least 6 months
- Body mass index ≥16 kg/m²
- Male or eligible female participants
You will not qualify if you...
- Current or prior diagnosis of asthma
- Other significant lung diseases where COPD is not primary
- Pneumonia, COPD exacerbation, or lower respiratory infection within 4 weeks prior to screening
- History or planned lung volume reduction surgery or endobronchial valve procedure
- Pulmonary rehabilitation within 4 weeks prior to screening
- Need for oxygen supplementation more than 12 hours per day
- Cor pulmonale causing right heart failure or severe pulmonary hypertension
- Chronic hypercapnia requiring non-invasive ventilation such as BiPAP or CPAP
- Unstable cardiovascular disease or arrhythmia
- Known parasitic infection within 6 months prior to screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 104 weeks
Participants receive depemokimab or placebo along with standard care as part of the treatment.
Visits as per treatment schedule during the 104 weeks
Trial Site Locations
Total: 15 locations
1
GSK Investigational Site
Loxahatchee Groves, Florida, United States, 33470
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2
GSK Investigational Site
Miami, Florida, United States, 33155
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3
GSK Investigational Site
Rock Hill, South Carolina, United States, 29732
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4
GSK Investigational Site
Corsicana, Texas, United States, 75110
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5
GSK Investigational Site
Changsha, Hunan, China, 410015
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6
GSK Investigational Site
Chengdu, Sichuan, China
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7
GSK Investigational Site
Chengdu, China, 610041
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8
GSK Investigational Site
Guangzhou, China, 510150
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9
GSK Investigational Site
Hangzhou, China, 310000
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10
GSK Investigational Site
Jiangmen, China, 529000
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11
GSK Investigational Site
Jiangxi, China
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12
GSK Investigational Site
Mianyang, China
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13
GSK Investigational Site
Qingyuan, China, 511500
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14
GSK Investigational Site
Zigong, China, 643036
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15
GSK Investigational Site
Tokyo, Japan, 140-8522
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Research Team
U
US GSK Clinical Trials Call Center
E
EU GSK Clinical Trials Call Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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